FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin
INCHEON, South Korea& JERUSALEM--(BUSINESS WIRE) December 14, 2018 --Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb), a HER2/neu... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 14, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tolsura (SUBA ®-itraconazole capsules) for the Treatment of Certain Fungal Infections
ADELAIDE, Australia, Dec. 11, 2018 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tolsura™ (SUBA®-itraconazole)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 11, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery
BEDFORD, Mass.--(BUSINESS WIRE)--Dec. 3, 2018-- Ocular Therapeutix™, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 3, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Firdapse (amifampridine) for Lambert-Eaton Myasthenic Syndrome
November 28, 2018 -- The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xospata (gilteritinib) for Acute Myeloid Leukemia (AML) with a FLT3 Mutation
November 28, 2018 -- The U.S. Food and Drug Administration today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Truxima (rituximab-abbs), a Biosimilar to Rituxan for Non-Hodgkin ’s Lymphoma
November 28, 2018 -- The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers
November 26, 2018 -- The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the second... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves The ACTpen for Actemra, A Single-Dose, Prefilled Autoinjector
South San Francisco, CA -- November 26, 2018 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Daurismo (glasdegib) for Patients with Acute Myeloid Leukemia
November 21, 2018 -- The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 21, 2018 Category: Drugs & Pharmacology Source Type: news

Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible For Intensive Induction Chemotherapy
South San Francisco, CA -- November 21, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Venclexta (venetoclax), in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Gamifant (emapalumab-lzsg) for Primary Hemophagocytic Lymphohistiocytosis
November 20, 2018 -- The U.S. Food and Drug Administration today approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 20, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Aemcolo (rifamycin) to Treat Travelers ’ Diarrhea
November 16, 2018 -- The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas
BOTHELL, Wash.--(BUSINESS WIRE)--Nov. 16, 2018-- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced a new approval for Adcetris (brentuximab vedotin) in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) from the U.S.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Promacta (eltrombopag) for First-Line Severe Aplastic Anemia
Basel, November 16, 2018 - Novartis announced today that the US Food and Drug Administration (FDA) has expanded the label for Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with severe... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)
November 09, 2018 -- Today, the U.S. Food and Drug Administration (FDA) approved Yupelri (revefenacin) Inhalation Solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 9, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib
KENILWORTH, N.J.--(BUSINESS WIRE) November 9, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 9, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma
RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 7, 2018 Category: Drugs & Pharmacology Source Type: news

Bausch Health Announces U.S. Launch of Bryhali (halobetasol propionate) Lotion, 0.01%, for Plaque Psoriasis In Adults
LAVAL, Quebec, Nov. 7, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced it expects to start... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 7, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta
REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 2, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer
November 2, 2018 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Lorbrena [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 2, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Dsuvia (sufentanil) Sublingual Tablets for Severe Pain
REDWOOD CITY, Calif., Nov. 2, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in a medically supervised... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 2, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sympazan (clobazam) Oral Film for Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome
WARREN, N.J., Nov. 2, 2018 /PRNewswire/ -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Sympazan™ (clobazam) oral film for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira
Holzkirchen, Germany, October 31, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, Hyrimoz (adalimumab-adaz). The FDA granted... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 31, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
KENILWORTH, N.J.--(BUSINESS WIRE) October 30, 2018 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 30, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Invokana (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
TITUSVILLE, NJ, October 30, 2018– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Invokana (canagliflozin) to reduce the risk of major adverse... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 30, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
BOCA RATON, Fla.--(BUSINESS WIRE)--Oct. 29, 2018-- TherapeuticsMD, Inc, an innovative women ’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved Bijuva (estradiol and progesterone) capsules,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 29, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xofluza (baloxavir marboxil) for the Treatment of Acute Uncomplicated Influenza
October 24, 2018 -- Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 24, 2018 Category: Drugs & Pharmacology Source Type: news

Spectrum Pharmaceuticals Receives FDA Approval of Khapzory (levoleucovorin) for Injection
HENDERSON, Nev.--(BUSINESS WIRE)--Oct. 23, 2018-- Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 23, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma
PARIS and TARRYTOWN, N.Y., Oct. 19, 2018 /PRNewswire/ -- Sanofi (EURONEXT: SAN) (NYSE: SNY) The U.S. Food and Drug Administration has approved Dupixent® (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 19, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
On October 16, 2018, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm),... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
DUBLIN and SAN FRANCISCO October 16, 2018 – Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Medicines360, a global nonprofit women’s health pharmaceutical company with a mission of expanding access to quality medicines,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Yutiq (fluocinolone acetonide intravitreal implant) for Chronic Non-Infectious Posterior Segment Uveitis
WATERTOWN, Mass., Oct. 15, 2018 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, announced today that the U. S. Food... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 15, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xarelto to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)
TITUSVILLE, NJ, October 11, 2018 – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 11, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Accelerated 7-Day Vaccine Dosing Schedule for Ixiaro
GAITHERSBURG, Md.--(BUSINESS WIRE) October 05, 2018 --Valneva USA, the U.S. subsidiary of global vaccine biotech company Valneva SE, today announced U.S. Food and Drug Administration (FDA) approval of an accelerated dosing regimen for Ixiaro... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tegsedi (inotersen) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
BOSTON and CARLSBAD, Calif., Oct. 05, 2018 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ: AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Revcovi (elapegademase-lvlr) for Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)
GAITHERSBURG, Md.--(BUSINESS WIRE) October 05, 2018 --Leadiant Biosciences, Inc. today announced that the Food and Drug Administration (FDA) has granted approval to Revcovi ™ (elapegademase-lvlr) injection in the U.S. Revcovi is a new enzyme... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Use of Gardasil 9 to Include Individuals 27 Through 45 Years Old
October 5, 2018 -- The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Hemlibra (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors
South San Francisco, CA -- October 4, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Hemlibra ® (emicizumab-kxwh) for routine prophylaxis to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 4, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections
BOSTON, Oct. 02, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the U.S. Food and Drug Administration (FDA) has approved Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 2, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Seysara (sarecycline) for the Treatment of Moderate to Severe Acne
Barcelona - 2nd October 2018 -- Almirall, S.A. announced today that the Food and Drug Administration (FDA) has approved Seysara (sarecycline), a new, innovative first in class tetracycline-derived oral antibiotic for the treatment of inflammatory... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 2, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xyosted (testosterone enanthate) Injection for Testosterone Replacement Therapy in Adult Males
EWING, N.J., Oct. 01, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ:ATRS) today announced the approval of Xyosted (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). Xyosted is the first FDA approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kyprolis (carfilzomib) Once-Weekly Kd70 Regimen for Relapsed or Refractory Multiple Myeloma
THOUSAND OAKS, Calif., Oct. 1, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for Kyprolis... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 1, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Arikayce (amikacin liposome inhalation suspension) to treat Mycobacterium Avium Complex (MAC) Lung Disease
September 28, 2018 -- The U.S. Food and Drug Administration today approved a new drug, Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Libtayo (cemiplimab-rwlc) for Advanced Cutaneous Squamous Cell Carcinoma
September 28, 2018 -- The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation
South San Francisco, CA -- September 28, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fycompa for the Treatment of Partial-Onset Seizures in Pediatric Patients as Young as 4 Years Old
WOODCLIFF LAKE, N.J., Sept. 28, 2018 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

Eisai Announces FDA Approval of Fycompa in Pediatric Patients as Young as 4 Years Old for the Treatment of Partial-Onset Seizures
WOODCLIFF LAKE, N.J., Sept. 28, 2018 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vizimpro (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer
September 27, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Vizimpro [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 27, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Emgality (galcanezumab-gnlm) for the Preventive Treatment of Migraine in Adults
INDIANAPOLIS, Sept. 27, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 27, 2018 Category: Drugs & Pharmacology Source Type: news